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Effects of Niaoduqing Particles (尿毒清颗粒) on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study

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Abstract

Objective

To follow up the participants of the randomized clinical trial “Efficacy and Safety of Niaoduqing Particles (尿毒清颗粒) for Delaying Moderate-to-Severe Renal Dysfunction”, and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction.

Methods

Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks (146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) after completion of the open-label treatment period.

Results

After the double-blind period, the median (interquartile range) changes in Scr were 1.1 (–13.0–24.1) and 11.7 (–2.6–42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively (P=0.008), and the median changes in eGFRs were–0.2 (–4.3–2.7) and–2.21 (–5.7–0.8) mL•min-1•1.73 m-2, respectively (P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0 (–10.0–41.9) and 17.5 (–6.0–50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively (P=0.214), and the median changes in eGFRs were–2.3 (–6.4–1.9) and–3.7 (–7.5–1.1) mL•min-1•1.73 m-2, respectively (P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 mL•min-1•1.73 m-2 per year.

Conclusion

Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function. (Trial registration No. ChiCTR-TRC-12002448)

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Acknowledgements

The authors would like to thank Drs. YAN Xiao-yan and YU Yong-pei from the Peking University Clinical Research Institute for statistical support, insightful suggestions, and comments on the study protocol; Drs. ZHANG Li, DUAN Shu-wei, LI Zuo-xiang, and FU Bo, from the Department of Nephrology, Chinese People’s Liberation Army General Hospital, for their help with various aspects of the study; the researchers from all 22 research centers, Drs. WEI Ri-bao, GAO Yu-wei, GA Li-ya, WU Yi-fan, CHE Xia-jing, QU Kai, CHEN Ji-lin, CUI Ying-chun, HUO Yan-hong, CHANG Qin-tao, WU Xing-lan, WU Shi-feng, SUN Shi-ren, WANG Li, ZHANG Ling-yun, ZHANG Jing-jing, YANG Yan-fang, SHI Wei, LIU Wen-hu, WANG Li, and XU Xue-qiang for their cooperation, encouragement, and enthusiasm in the clinical trial; and the study participants for their trust and inspiration to the authors.

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Correspondence to Guang-yan Cai or Xiang-mei Chen.

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Supported by the National Key Technology R&D Program (No. 2015BAI12B06), Key Program of National Natural Science Foundation of China (No. 81330019), General Program of National Natural Science Foundation of China (No. 81670671), and the Beijing Science and Technology Project (No. D171100002817002, D181100000118002, and D181100000118004)

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Zheng, Y., Wang, Ns., Liu, Yn. et al. Effects of Niaoduqing Particles (尿毒清颗粒) on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study. Chin. J. Integr. Med. 25, 168–174 (2019). https://doi.org/10.1007/s11655-018-2998-y

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